Alaka'ina Foundation Family of Companies Human Subjects Protection SME in Silver Spring, Maryland
Human Subjects Protection SME
MD - Silver Spring
Laulima Government Solutions is seeking a Human Subjects Protection Subject Matter Expert to work on our Walter Reed Army Institute of Research (WRAIR) contract in Silver Springs, Maryland.
Human Subjects Protection SME Description of Responsibilities:
• Reviews and writes a variety of scientifically technical documents for the purposes of evaluating against applicable regulations, policies and procedures.
• Provides human subjects protection regulatory and scientific support services via the review of research protocols submitted to an Army command and its detachments.
• Evaluating research protocols and protocol lifecycle actions for compliance with relevant regulatory requirements and drafting a protocol evaluation form (PEF)/pre-review for each review conducted. PEFs/pre-reviews shall be completed within 15 business days or within a period of time defined by the human subject’s protection branch (HSPB) Director. No more than 2 deviations are acceptable annually.
• Managing the approval process for these actions by drafting/triaging review/approval memoranda on behalf of the army command and its detachments. Approval memoranda shall be drafted in accordance with existing templates and within 3 days of a completed action. No more than 2 deviations are acceptable annually.
• Developing new policies/procedures, as well as, recommend revisions to existing policies and procedures, at the request of the TOCOR or HSPB Director. Policy revisions and recommendations shall be drafted within 2 weeks of assignment. Employee shall complete requested policies by the due date 95% of the time.
• Representing HSPB at meetings pertaining to human subject protection issues, as needed.
• Participating in site assistance visits to OCONUS laboratories, as needed, and draft site assistance visit (SAV) reports following visits to OCONUS laboratories with 2 weeks of visit. Employee shall complete required draft report by the due date 95% of the time.
• Reviewing and documenting investigator’s credentials. The PEF/pre-review will include review and documentation of investigator credentials. PEFs/pre-reviews will be completed within 15 business days or within a period of time defined by the HSPB Director. No more than 2 deviations are acceptable annually.
• Writing protocol minutes and provision of meeting minutes’ excerpts (referred to as ‘Communications to PI’). Employee shall provide Communications to PI to TOCOR or HSPB Director for review within 5 working days of the IRB meeting. Employee shall complete communications by the due date 95% of the time.
• Providing training in human subjects’ protection and quality of records to investigators and other staff, as needed.
• Updating the HSPB protocol database/electronic records management system in a timely manner and maintain electronic and paper regulatory files within 3 days of receipt of the lifecycle action. Employee shall complete entries/updates by the due date 95% of the time.
• Maintaining a safe workplace, ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures.
• Assisting in providing support in preparation for IRB meetings, to include preparing/participating in pre-meetings, as well as, setting up/clearing up the room for the day of the meeting.
• Master’s degree in a relevant scientific field of study OR a Registered Nurse (RN) with a corresponding Bachelor’s degree and research and regulatory experience.
• Bachelor’s degree in a scientific field with a minimum of 6 years of research and regulatory experience will also be considered.
• Must be eligible for, or already hold, one of the following certifications: CIP, RAC, CCRP
Required Skills and Experience:
• A minimum of 3 years of research and regulatory experience.
• A minimum of 3 years of human subject’s protection and IRB experience.
• Ability to serve as the subject matter expert in required areas of expertise and provide industry best practice solutions to extremely complex problems being addressed.
• Have the ability to analyze extremely complex problems and recommend, monitor and execute best practice solutions to executive level management.
• Good written and oral communication skills, along with the ability to work well in teams.
Desired Skills and Experience:
• Understanding of and proficiency in Endnote Citation Management Software, Adobe Photoshop CS6, Microsoft Office, Outlook, and databases.
Laulima Government Solutions LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays.
For additional information on Laulima Government Solutions, LLC, please
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.